1. Field of the Invention
The present invention relates, generally, to a urinary-control device employed to combat male incontinence and, more particularly, to a urethra clamp.
2. Description of the Related Art
Incontinence—the uncontrolled and undesired passage of urine—is a problem faced by many men and, especially, older men. Incontinence may be caused by, for example, medical operations, partial or full sphincter loss, disease, neurological dysfunction, malformation of the urethral valve, and physical deterioration accompanying advancing age such that the natural urethral valve or sphincter is no longer capable of controlling the flow of urine from the bladder. Whatever the cause, incontinence is a significant problem resulting in distress, embarrassment, inconvenience, and restriction of activities.
It is known in the related art to prevent involuntary flow of urine in incontinent males by clamping the penis via particular devices that cause pressure to be applied upon the urethra, which, consequently, restricts flow of urine through the penis. Devices of this type are typically positioned about and tightened around the shaft of the penis until sufficient pressure is applied to the corpus spongiosum, in general, and the urethra, in particular, to substantially or completely close the urethra. Many of the devices known in the related art include a rigid or resilient projection that is positioned beneath the urethra and corpus spongiosum when mounted to the penis. The projection acts to apply the necessary pressure to clamp the urethra. The device is loosened or removed from the penis to permit flow of urine through the urethra when appropriate.
While clamping devices of the type known in the related art can create sufficient pressure to stop flow of involuntary urine to a penis of a particular size in a flaccid state, they suffer from the disadvantage in that they cannot create sufficient pressures to stop flow of involuntary urine to penises of various sizes in a flaccid state. More specifically, they cannot ensure that sufficient pressure is applied to the urethra and the corpus spongiosum of each of many penises of various sizes in a flaccid state to prevent or substantially reduce leakage from the urethra. They are not selectively and variably adjustable to enable application of different pressures to the urethra and the corpus spongiosum to accommodate needs of individual users. Leakage from the urethra caused by this inability of the clamping devices known in the related art is a major drawback of the urinary-control devices presently available on the market.
Clamping devices of the type known in the related art also suffer from the disadvantage in that they often reduce or stop blood flow through the penis. More specifically, while ensuring that sufficient pressure is applied to the urethra and the corpus spongiosum to prevent or substantially reduce leakage from the urethra, the devices apply undue pressure to the penile shaft. This unacceptable and sometimes painful amount of pressure is applied to tissues other than the urethra and corpus spongiosum. In particular, the devices apply undue pressure to a group of penile elements lying just below or close to the epidermal layer of the penis, including the superficial dorsal vein, superficial lateral veins, helicine arteriole, cavernosal artery, corpus cavemosum, tunica albuginea, superficial lateral vein, and emissary vein. This group will be referred to hereinafter as the neurovascular bundle. Unfortunately, excessive pressure applied to the neurovascular bundle can result in reduced blood flow through the penis and even necrosis of the penile tissue. Reduced blood flow caused by the clamping devices known in the related art is very uncomfortable and a major drawback of the urinary-control devices presently available on the market.
Urinary-control devices of the type known in the related art can also be difficult or cumbersome to properly position on the shaft of the penis. Some are difficult to release when the user voluntarily attempts to empty his bladder, causing undue delay and embarrassment. Still others suffer from the disadvantage that they are bulky and relatively heavy and, therefore, increase the discomfort associated with using these devices. Finally, while male urinary-control devices of the type known in the related art generally clamp the urethra so as to stop unwanted flow therethrough, they are uncomfortable to wear for extended periods of time.
Thus, there is a need in the related art for a urinary-control device for male incontinence that allows for delivery of different pressures to the urethra and the corpus spongiosum as a function of various sizes of penises in a flaccid state. More specifically, there remains a need in the related art for a urinary-control device employed to combat male incontinence that is selectively and variably adjustable to enable application of different pressures to the urethra and the corpus spongiosum to accommodate needs of individual users. There is a need in the related art for a urinary-control device that also allows for improved blood flow through the penis and is more convenient; easier to attach, remove, and use; and more comfortable than the clamping devices of the related art and relatively streamlined and lightweight. More specifically, there remains a need in the related art for a urinary-control device employed to combat male incontinence that uses a quick-release mechanism for one-handed operation so as to facilitate easy proper positioning on the penile shaft and removal therefrom for urination. There is a need in the related art for a urinary-control device that also is selectively and variably adjustable to enable application of different pressures to the penis to accommodate needs of individual users. There remains a need in the related art for a urinary-control device that also does not inflict pain, trauma, and/or damage to the neurovascular bundle so that the device may be comfortably worn by a user for extended periods of time without removal, except to permit urination. Finally, there is a need in the related art for a urinary-control device that also addresses all of the deficiencies of the known devices and is simple and inexpensive to construct.